Data set definitions and list of analyses
24-Week placebo controlled period | All Bari-RA | Haematological extended set | JADV | Platelets extended set* | Baseline JADV, JADX | JADN | |||
---|---|---|---|---|---|---|---|---|---|
Data sets definition | Placebo-controlled periods through 24 weeks | All patients with RA with ≥1 dose of Bari | Placebo controlled periods and LTE, studies with LTE option only | Study-specific analyses | Placebo controlled periods and LTE | Study-specific analysis | Study-specific analyses | ||
Treatment | Placebo, Bari 4 mg | Bari 2 mg | Bari 1, 2, 4, 5, 7, 8, 10 or 15 mg once daily or 2 mg two times per day | Placebo, Bari 4 mg | Bari 2 mg | Bari 4 mg | Bari 4 mg | NA | Placebo, Bari 2 mg, Bari 4 mg |
Studies | JADA, JADC, JADN, JADV, JADW, JADX | JADA, JADN, JADW, JADX | JADA, JADB, JADC, JADN, JADV, JADW, JADX, JADZ and LTE | JADA, JADV, JADW, JADX and LTE | JADA, JADW, JADX and LTE | JADV | JADA, JADC, JADN, JADV, JADW, JADX, JADZ and LTE | JADV, JADX | JADN |
Censoring | At rescue | None | At rescue or dose change | At rescue | At rescue or dose change | NA | NA | ||
List of analyses | |||||||||
Baseline characteristics (table 3) | X | X | X | ||||||
Infection by CTCAE Grade (table 4) | X | X | |||||||
AEs leading to d/c (table 5) | X | X | X | ||||||
Neutrophils and lymphocytes over time (figure 1) | X | X | |||||||
Platelets over time (figure 2) | X | X | |||||||
Change in haemoglobin over time (figure 3) | X | X | |||||||
Reversibility (figures 1B, D and 2B) | X | X | |||||||
Neutrophils by hsCRP (online supplemental figure 1) | X | ||||||||
Platelets over time by baseline platelet quartile (online supplemental figure 2) | X | ||||||||
Mean platelet count and volume (online supplemental figure 3) | X | ||||||||
Thrombocytosis by DVT/PE or no (online supplemental figure 4) | X | ||||||||
Baseline haemoglobin by hsCRP cat., gender, and age (online supplemental figure 5) | X | ||||||||
Haemogloblin over time by baseline hsCRP quartile (online supplemental figure 6) | X (Bari 4 mg only) | ||||||||
Change in erythropoetin, reticulocytes and RBC over time (online supplemental figure 7) | X | ||||||||
Change in total iron-binding capacity (online supplemental figure 8) | X | ||||||||
Platelet count shift (online supplemental table 1) | X | X | |||||||
Baseline anaemia by prior medications (online supplemental table 2) | X |
* Data for the follow-up period after treatment discontinuation are included in this analysis.
AEs, adverse events; Bari, baricitinib; cat., category; CTCAE, Common Terminology Criteria for Adverse Events; DVT/PE, deep vein thrombosis/pulmonary embolism; hsCRP, high-sensitivity C reactive protein, LTE, long-term extension (JADY study); NA, not applicable; RA, rheumatoid arthritis; RBC, red blood cell.